Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:26 AM
Study NCT ID:
NCT07433634
Status:
RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time to BBVNA Relief
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants achieving clinical response', 'timeFrame': '2 years', 'description': 'Clinical response defined as a ≥50% reduction in pain intensity from baseline as measured by the Visual Analog Scale (VAS) or a ≥15-point improvement in the Oswestry Disability Index (ODI) score'}], 'secondaryOutcomes': [{'measure': 'Change in PROMIS-7 Global Health Score', 'timeFrame': '2 years', 'description': '7-item, self-report, or parent-proxy tool designed to assess overall physical, mental, and social health using a 5-point Likert scale., score range 20-80. It generates a T-score, where 50 is the U.S. population average and 10 is the standard deviation. Higher scores indicate better overall health.'}, {'measure': 'Percentage of participants with incresed physical activity assessed using Physical Activity Vital Sign (PAVS)', 'timeFrame': '2 years', 'description': '2-question screening tool used in clinical settings to assess if adults meet the recommended 150+ minutes of weekly moderate-to-vigorous physical activity. Calculate the total weekly minutes of exercise by multiplying #1 times #2.'}, {'measure': 'Incidence of spine-related interventions', 'timeFrame': '2 years', 'description': 'Incidence of further spine-related interventions (e.g., epidural steroid injections, radiofrequency ablation, or spine surgery) post-BVN ablation.'}, {'measure': 'Patient Global Impression of Change (PGIC) score', 'timeFrame': '2 years', 'description': "Self-report 7-point scale measuring a patient's belief regarding the effectiveness of a treatment with higher scores indicating a better outcome. Score range 1-7."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain relief trajectory', 'Basivertebral nerve ablation', 'Vertebrogenic low back pain,', 'Responder phenotypes', 'Clinical Outcomes', 'Radiofrequency Ablation'], 'conditions': ['Low Back Pain', 'Vertebrogenic Pain Syndrome', 'Basivertebral Nerve Ablation']}, 'descriptionModule': {'briefSummary': 'Basivertebral nerve ablation (BVNA) is a minimally invasive procedure approved for vertebrogenic low back pain. While early studies support its efficacy, real-world evidence is still evolving, particularly regarding the trajectory of pain relief and functional improvement over time, and predictors of clinical response. This study aims to evaluate clinical outcomes longitudinally following BVNA and identify baseline predictors of response.', 'detailedDescription': 'Primary Objective:\n\n• To determine the proportion of patients achieving clinical response (defined as ≥50% reduction in VAS or ≥15-point improvement in ODI) following BVNA.\n\nSecondary Objectives:\n\n* To assess changes in PROMIS-7, PAVS, and other patient-reported outcomes.\n* To determine the incidence of further interventions such as epidural steroid injections (ESIs) or surgeries.\n* To evaluate temporal trends in response and adverse events. A total of 11 visits inclusive of follow up visits with schedule for study intervals. 1 baseline visit, 8 virtual/ phone weekly visits, 1 3-month virtual visit , 1 6-month , 1 12-month and 1 24-month visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will compromise all healthy adults presenting to the outpatient orthopedic and rehabilitation clinic with symptoms of vertebrogenic low back pain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of chronic axial low back pain with vertebrogenic features\n* Scheduled for BVN ablation\n* Able to provide informed consent\n* Capable of participating in weekly virtual/telephone follow-up for 8 weeks and in- person or remote follow-up at 3 and 6 months through 2 years\n\nExclusion Criteria:\n\n* Prior spinal neuromodulation therapy (e.g., spinal cord stimulation or intrathecal pump) within the past 6 months\n* Active substance use disorder or uncontrolled psychiatric illness that may interfere with participation\n* Cognitive impairment limiting ability to complete surveys or provide informed consent\n* Pregnancy\n* Incarceration or current status as a prisoner'}, 'identificationModule': {'nctId': 'NCT07433634', 'briefTitle': 'Time to BBVNA Relief', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Temporal Trends and Predictors of Clinical Response Following Basivertebral Nerve (BVN) Ablation: A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': '2000040858'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Basivertebral nerve ablation', 'type': 'PROCEDURE', 'otherNames': ['Basivertebral Nerve Radiofrequency Ablation'], 'description': 'Participants underwent fluoroscopically guided intraosseous basivertebral nerve ablation (BVNA) using the Intracept® System (Boston Scientific, MA, USA) targeting MRI-confirmed Modic type 1 or 2 vertebral endplate changes. Procedures were performed under general anesthesia via a transpedicular or parapedicular approach with biplanar fluoroscopic confirmation of probe placement at the basivertebral foramen (30-50% vertebral body depth, midline AP position). Thermal radiofrequency ablation was delivered using either 75°C for 7 minutes (targeted lesion) or 85°C for 15 minutes (expanded lesion), selected based on intraoperative probe proximity to the intended target to optimize nerve capture. Only levels with imaging-confirmed Modic changes were treated. Weekly patient-reported outcomes were collected for 8, 12, 24 , 48 through 98 weeks.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06437', 'city': 'Guilford', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale Spine and Pain Center - Guilford', 'geoPoint': {'lat': 41.28899, 'lon': -72.68176}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale Pain Management Center - New Haven', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06475', 'city': 'Old Saybrook', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale Interventional Spine and Musculoskeletal Medicine - Old Saybrook', 'geoPoint': {'lat': 41.29177, 'lon': -72.3762}}], 'centralContacts': [{'name': 'Charles A Odonkor, MD', 'role': 'CONTACT', 'email': 'kcodonkor@aya.yale.edu', 'phone': '203-767-1555'}, {'name': 'Muhammad U Siddique, MD', 'role': 'CONTACT', 'email': 'muhammad.siddique@yale.edu', 'phone': '203-668-2772'}], 'overallOfficials': [{'name': 'Charles A Odonkor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}